Phase I, Open Label, Single Dose Study to Determine the Pharmacokinetics, Metabolism, and Excretion of [14C]- Evobrutinib in Healthy Participants

Completed

• Conditions: Multiple Sclerosis; Rheumatoid Arthritis; 10003816

• Registration Number: NL-OMON46168
• Lead Sponsor: PRA Health Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. 18-55 years of age at the time of signing the informed consent.
2. Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring.
3. Have a body weight within 50.0 and 120.0 kg (inclusive) and Body Mass Index (BMI) within the range 19.0 - 30.0 kg/m2 (inclusive).
4. Male

Exclusion Criteria

1. History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
2. Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to screening.
3. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.
4. History of any malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the rates and routes of excretion of total radioactivity,<br /><br>including mass balance of total drug-related radioactivity in urine and feces<br /><br><br /><br>To determine the PK of total radioactivity in blood and plasma<br /><br><br /><br>To characterize the plasma PK of evobrutinib</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of a single oral 75 mg dose of<br /><br>[14C]-evobrutinib administered to healthy male participants</p><br>